RecruitingNot ApplicableNCT06570135
Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
Sponsor
Xijing Hospital
Enrollment
20 participants
Start Date
Apr 8, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain activity in resting and task states (Simulated Sex) between the two groups of patients.
Eligibility
Sex: MALEMin Age: 18 YearsMax Age: 45 Years
Inclusion Criteria11
- patients' age varied from 18 to 45 years;
- patients met the 2014 International Society for Sexual Medicine (ISSM) definition criteria for PPE;
- patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
- Patients with premature ejaculation lasting longer than 6 months;
- patients were identified if their scores were higher than 9 on the Chinese version of Premature Ejaculation Diagnostic Tool (PEDT);
- patients had no history of any previous therapies for PE or had recently stopped the therapies for at least 3 months
- patients had fully informed consent, signed informed consent form
- Men between the ages of 18-45 years were included according to an age difference of \<3 years between each patient and the primary premature ejaculation group, and if more than one volunteer was eligible at the same time, the one with the closest age was selected;
- Patient does not meet the 2014 International Society for Sexual Medicine (ISSM) criteria for defining premature ejaculation;
- patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
- patients had fully informed consent, signed informed consent form;
Exclusion Criteria7
- patients were diagnosed with secondary PE, variable PE, and subjective PE;
- patients were using medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases;
- patients were abusing alcohol or illegal drugs;
- patients were diagnosed with erectile dysfunction (ED) if their scores were \<21 on the abridged five-item International Index of Erectile Function (IIEF-5)
- patients were diagnosed with sexual hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infection;
- patients with head injuries that prevent them from completing near-infrared light brain function imaging
- Patients with severe schizophrenia, anxiety, depression or other neurological symptoms or poor compliance
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Interventions
DIAGNOSTIC_TESTDetecting Brain Activity with Functional Near Infrared Spectroscopy
Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06570135
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